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A Phase Ib Study of RC1416 Injection

NCT06911866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-30

No results posted yet for this study

Summary

This is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RC1416 injection in patients with moderate to severe asthma.

Conditions

  • Moderate to Severe Asthma

Interventions

DRUG

RC1416

there are four doses(200mg-400mg) in this part. Each subjects will receive the drug once by subcutaneous injection.

DRUG

RC1416 Placebo

Each subjects will receive the placebo once by subcutaneous injection.

Sponsors & Collaborators

  • Nanjing RegeneCore Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-25
Primary Completion
2025-09-25
Completion
2025-09-25
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06911866 on ClinicalTrials.gov